Module 16 2024

24/10/2024

Draft PMS SI Periodic Safety Update Report (PSUR) and ABs

AB involved when:

AB requirements:

No AB review required:

• manufacturer is placing device on the GB market after fulfilling the requirements of MDR 2002 Regulation 19B, 19C, 30A, 44ZA or 44ZB (devices that bear the CE mark). • any IVD which is NOT included in the lists of Directive 98/79/EC Annex II. • device is a System or Procedure pack in accordance with UK MDR 2002 Regulation 14 (unless system or procedure pack contains one or more component device which is not UKCA-marked (or CE marked) or is to be used outside its intended purpose and therefore be required to undergo an appropriate conformity assessment procedure, in which case the Approved Body is required to review the PSUR)

• AB contracted with the medical device manufacturer

• receive all (initial and updated) PSUR documents submitted by manufacturers • review the PSUR documents for particular groups of devices • produce a report setting out the conclusions of the review for certain devices • decide on whether certification has been impacted and any subsequent actions

• AB issued a UKCA conformity assessment certificate for a device which has been placed on the GB market

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

17

17

Draft PMS SI Periodic Safety Update Report (PSUR) and ABs

MDCG 2022-21 PSUR guidance – UK guidance expected

PSUR documents submitted by manufacturers

AB requirements

AB Review and Report

• receive all (initial and updated) PSUR documents submitted by manufacturers • review the PSUR documents for certain groups of devices • produce a report setting out the conclusions of the review for certain devices • decide on whether certification has been impacted and any subsequent actions

• Review • Report • Review • Report

Class III/AIMD

Class III/AIMD

• Every year

Guidance on timelines for review?

IIb

• Every Year

IIb

(implantable only)

IIa

• Every 2 years

IIa

• Review

Non Self declared IVDs

Non Self declared IVDs

• Review • Report

• Every Year

Similar requirements to EU MDR Article 86 for submission & Notified Body Review

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

18

18

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